Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001183673
Ethics application status
Approved
Date submitted
28/10/2014
Date registered
11/11/2014
Date last updated
2/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a periodontal intervention on renal health in Aboriginal Australian adults with kidney disease
Scientific title
The effect of a periodontal intervention on renal health in Aboriginal Australian adults with kidney disease
Secondary ID [1] 285552 0
Nil
Universal Trial Number (UTN)
U1111-1163-4315
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal disease
 293371 0
Periodontal disease 293408 0
Condition category
Condition code
Renal and Urogenital 293655 293655 0 0
Kidney disease
Oral and Gastrointestinal 293690 293690 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Periodontal treatment, including scaling, root planing and extraction of teeth considered unable to be saved. Sessions will take between 30 to 60 minutes and will occur at three time points by a registered dental professional. The time points will be baseline, 1 month and 2 months (that is, each session separated by a month)
Intervention code [1] 290497 0
Treatment: Surgery
Intervention code [2] 290529 0
Treatment: Other
Comparator / control treatment
No peridontal intervention
Control group
Active

Outcomes
Primary outcome [1] 293467 0
Renal function as assessed by analysis of serum creatinine and estimated Glomerular Filtration Rate (eGFR).
Timepoint [1] 293467 0
three, twelve and twenty-four months
Secondary outcome [1] 311109 0
Progression of cardiovascular disease as assessed by carotid intima media thickness (cIMT). CIMT will be assessed by ultrasonography of carotid arteries.
Timepoint [1] 311109 0
three, twelve and twenty-four months
Secondary outcome [2] 311180 0
Death
Timepoint [2] 311180 0
three, twelve and twenty-four months

Eligibility
Key inclusion criteria
Aboriginal adults living in Central Australia with chronic kidney disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to sign informed consent form

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment through community health workers; allocation through a random number generator. Randomisation will be done using field staff laptop computers. The field staff will be required to register the participants in the trial prior to identifying the randomised group. These data will be unable to be altered, thus allowing the randomisation process to be audited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation through a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of covariance (ANCOVA) will be performed to determine differences in the primary outcome (renal function) between the two groups and over time, using a conservative F-test for the interaction between time and treatment. Death, a binary outcome, will be analysed using the chi-square test with frequencies and percentages per treatment arm and odds-ratios or other measures of treatment effect reported along as summary measures. The Greenhouse-Geisser correction for the F-test will be used to adjust the degrees of freedom for deviation from sphericity. Logarithmic transformation of the data will be performed where appropriate. A post hoc correlation analysis by the Spearman rank-correlation method will be performed to evaluate the relationship between the changes in renal function from baseline to three, twelve and twenty four months following periodontal therapy. Effect sizes will be calculated by dividing the mean of change scores by the pooled estimate of the standard deviation. Effect measures will also be presented through calculation of number-needed-to-treat and its associated 95% confidence interval. The statistically significant level will be at P<0.05.

Based on a recent study of Australian Aboriginal adults with periodontal disease, it was estimated that a sample size of 472 would be necessary to detect a 4% difference in cIMT (from 0.82 to 0.79 mm) at the significance criterion of 0.05 and a power of 0.80. Allowing for 20% attrition, 592 participants would be necessary at base-line, rounded to 600 for convenience.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/04/2015
Actual
Date of last participant enrolment
Anticipated
1/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 3091 0
Alice Springs Hospital - Alice Springs

Funding & Sponsors
Funding source category [1] 290156 0
Government body
Name [1] 290156 0
National Health and Medical Research Council (NHMRC)
Country [1] 290156 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
The University of Adelaide
Adelaide, South Australia
5005 Australia
Country
Australia
Secondary sponsor category [1] 288865 0
None
Name [1] 288865 0
Address [1] 288865 0
Country [1] 288865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291866 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 291866 0
The University of Adelaide
Adelaide, South Australia
5005 Australia
Ethics committee country [1] 291866 0
Australia
Date submitted for ethics approval [1] 291866 0
31/10/2014
Approval date [1] 291866 0
21/01/2015
Ethics approval number [1] 291866 0
H-2014-249

Summary
Brief summary
The primary purpose of the study is to determine if comprehensive periodontal treatment reduces progression of kidney disease among Aboriginal Australians living in Central Australia with kidney disease. The study hypothesis is that periodontal treatment will reduce progression of kidney disease. Kidney disease is a growing public health concern in Australia, especially among Aboriginal populations. Kidney disease consumes disproportionate healthcare resources and is the most common cause of hospitalisation among Aboriginal Australians. In spite of the unacceptably high social, medical and financial burden caused by kidney disease, there have been few RCTs that explore the impact of treatment to address key risk factors, such as periodontal disease, on, kidney disease progression . As a consequence, the management armamentarium currently available to slow the kidney disease progression is extremely limited and only partially effective.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a

Contacts
Principal investigator
Name 52338 0
Prof Lisa Jamieson
Address 52338 0
The University of Adelaide
Adelaide, South Australia
5005 Australia
Country 52338 0
Australia
Phone 52338 0
+61 8 8313 4611
Fax 52338 0
Email 52338 0
[email protected]
Contact person for public queries
Name 52339 0
Prof Lisa Jamieson
Address 52339 0
The University of Adelaide
Adelaide, South Australia
5005 Australia
Country 52339 0
Australia
Phone 52339 0
+61 8 8313 4611
Fax 52339 0
Email 52339 0
[email protected]
Contact person for scientific queries
Name 52340 0
Prof Lisa Jamieson
Address 52340 0
The University of Adelaide
Adelaide, South Australia
5005 Australia
Country 52340 0
Australia
Phone 52340 0
+61 8 8313 4611
Fax 52340 0
Email 52340 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23358Analytic code  [email protected]
23359Informed consent form  [email protected]
23360Study protocol    367320-(Uploaded-06-02-2020-13-13-45)-Study-related document.pdf
23361Ethical approval  [email protected]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePeriodontal disease and chronic kidney disease among Aboriginal adults; An RCT.2015https://dx.doi.org/10.1186/s12882-015-0169-3
N.B. These documents automatically identified may not have been verified by the study sponsor.